ViiV HEALTHCARE PRESENTS NEW DATA DEMONSTRATING POSITIVE REAL-WORLD IMPACT OF ITS INNOVATIVE LONG-ACTING INJECTABLES FOR HIV AT IAS 2025
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- Real-world and implementation data describe effectiveness of long-acting Vocabria + Rekambys (cabotegravir + rilpivirine LA (CAB+RPV LA)) for HIV treatment and assess experiences of using Apretude (cabotegravir long-acting (CAB LA) for PrEP) in range of populations
- New phase IIIb data look at preferences among treatment-naive adults offered the choice to switch to CAB+RPV LA after attaining rapid viral suppression with Dovato (DTG/3TC) daily oral therapy
- Interim data from wave three of the Positive Perspectives study demonstrate impact of joint decision-making on HIV treatment satisfaction and health outcomes
London, 8 July 2025 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the presentation of abstracts from its innovative HIV treatment and prevention portfolio at the International AIDS Society 2025 Conference (IAS 2025) in Kigali, Rwanda. Key data will highlight the long-term effectiveness of Vocabria & Rekambys, (branded as Cabenuva in the US, Canada and Australia) the company’s complete long-acting injectable regimen for treatment; evaluate patient preference for long-acting injectables compared to daily oral therapy; and measure benefits of long-acting injectables in tackling common challenges associated with taking daily pills, including stigma and adherence.
Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: “Our extensive real-world insights about CAB+RPV LA for HIV treatment and CAB LA for HIV prevention demonstrate how long-acting injectables are redefining the way we approach HIV care and management in broad populations. The new real-world and implementation data at IAS 2025 further reinforce their effectiveness, safety and tolerability, and underscore our commitment to delivering therapies that meet the evolving needs of people impacted by HIV, offering flexibility and choice beyond daily oral treatment.”
Key data to be presented at IAS 2025 by ViiV Healthcare and its study partners include:
New data assessing preference and choice to switch to CAB+RPV LA after attaining rapid viral suppression: First data from the phase IIIb VOLITION study assessed preferences and experiences among ART-naive adults offered the option to switch to CAB+RPV LA after achieving rapid viral suppression with daily Dovato (dolutegravir/lamivudine (DTG/3TC).1
Growing body of real-world effectiveness data for CAB+RPV LA in broad range of populations: New data will be presented on outcomes including effectiveness, adherence, and satisfaction with CAB+RPV LA, from several real-world studies, including COMBINE-2, and two-year data from CARLOS and BEYOND.2,3,4,5 In addition, two analyses from the OPERA cohort will focus on the effectiveness of CAB+RPV LA in real-world settings for treatment-experienced adults with viremia at therapy initiation.6,7
New implementation data on acceptability and benefits of CAB LA for PrEP: Data from the PILLAR and EBONI implementation studies will focus on participant experiences with CAB LA implementation among men who have sex with men and transgender men, as well as healthcare provider experiences implementing CAB LA for Black women, respectively.8,9
New effectiveness data for DTG/3TC in different populations: New data from VOLITION evaluate the efficacy of DTG/3TC in achieving rapid virologic suppression in a diverse treatment-naive population.10 Data from investigator-led, ViiV Healthcare-supported studies, D2ARLING and SUNGURA will also be presented, including D2ARLING’s comparison of DTG/3TC effectiveness to other regimens in the presence of transmitted resistance mutations, and an analysis from the SUNGURA study including safety and efficacy data in virally suppressed older people living with HIV switching to DTG/3TC from BIC/FTC/TAF.11,12
Positive Perspectives wave three data highlighting the importance of community perspectives in treatment outcomes: Interim results from wave three of the Positive Perspectives study will be presented, showing how shared decision making and treatment satisfaction are linked to treatment outcomes and self-rated health in specific sub-group analyses.13 Additionally, the continued need to improve awareness, belief and confidence in U=U will be presented.14
ViiV Healthcare-sponsored or supported studies to be presented at IAS 2025:
Title |
Presenting author |
Presentation |
CAB+RPV LA | ||
Real-world effectiveness of CAB+RPV LA in individuals with HIV viremia at therapy initiation | R. Hsu | Oral Abstract OAB0104 15 July 2025 10:45 AM – 11:45 AM CAT |
24-month outcomes of cabotegravir+rilpivirine long-acting every 2 months in a real world setting: effectiveness, adherence to injections, and participant-reported outcomes from people with HIV-1 in the German CARLOS cohort | J. Scherzer | Poster Exhibition TUPEB035 15 July 2025 12:00 PM – 13:00 PM CAT |
Clinical outcomes among women in the OPERA Cohort initiating CAB+RPV LA with viral loads ≥ 50 copies/mL | V. Vannappagari | Poster Exhibition WEPEB036 16 July 2025 12:00 PM – 13:00 PM CAT |
Perspectives of people with HIV (PWH) 24 months following a switch to cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world US study (BEYOND) | C. Garris | Poster Exhibition THPEB036 17 July 2025 12:00 PM – 13:00 PM CAT |
The power of choice: strong preference for CAB+RPV LA following rapid suppression with DTG/3TC in newly diagnosed people living with HIV | C. Gutner | E-Poster EP0170 |
High virologic suppression and few virologic failures with Long-Acting Cabotegravir + Rilpivirine in Treatment Experienced Virologically Suppressed Individuals from COMBINE-2 cohort in Europe | A. Pozniak | E-Poster EP0171 |
Clinical Outcomes at Month 24 After Initiation of Cabotegravir and Rilpivirine Long Acting (CAB+RPV LA) in an Observational Real-World Study (BEYOND) | G. Blick | E-Poster EP0178 |
CAB LA for PrEP | ||
One-Year Implementation Outcomes of Cabotegravir Long-Acting Injectable PrEP in Men who Have Sex with Men (MSM) & Transgender Men (TGM): Findings from the PILLAR Study | D. Dandachi | Poster Exhibition TUPEE116 15 July 2025 12:00 PM – 13:00 PM CAT |
Health Care Provider Experiences After 12 Months of Implementing Cabotegravir Long-Acting Injectable PrEP (CAB LA) for Black Women: Results from the EBONI Study | Z. Tims-Cook | Poster Exhibition THPEE096 17 July 2025 12:00 PM – 13:00 PM CAT |
DTG/3TC | ||
Rapid virologic suppression with DTG/3TC facilitates early switch to CAB+RPV LA for treatment-naive people living with HIV: suppression phase outcomes from the phase 3b VOLITION study | B. Jones | Poster Exhibition WEPEB033 16 July 2025 12:00 PM – 13:00 PM CAT |
Efficacy of dolutegravir plus lamivudine in treatment-naïve people with HIV with baseline transmitted drug-resistance mutations: a subanalysis of the D2ARLING study | E. Cordova | E-Poster EP0172 |
Positive Perspectives | ||
Treatment Satisfaction was Linked to Improved Adherence, and Mental, Physical, Sexual and Overall Health Among People Living with HIV in the Positive Perspectives 3 Study | R. Patel | Poster Exhibition WEPED080 16 July 2025 12:00 PM – 13:00 PM CAT |
Data from the Positive Perspectives 3 Study Highlights the Continued Need for Expansion of Awareness, Belief and Confidence in Undetectable Equals Untransmittable (U=U) | N. Nwokolo | E-Poster EP0597 |
Joint Patient-Provider Decision Making was Associated with Improvements in Quality of Life and Treatment Satisfaction for People Living with HIV in the Positive Perspectives 3 study | R. Patel | E-Poster EP0608 |
APRETUDE (cabotegravir) extended-release injectable suspension
Professional Indication and Important Safety Information
INDICATION
APRETUDE is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION
Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen.
CONTRAINDICATIONS
- Do not use APRETUDE in individuals:
- with unknown or positive HIV-1 status
- with previous hypersensitivity reaction to cabotegravir
- receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine
WARNINGS AND PRECAUTIONS
Comprehensive Management to Reduce the Risk of HIV-1 Infection:
- Use APRETUDE as part of a comprehensive prevention strategy, including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition. Risk for HIV-1 acquisition includes, but is not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner[s] HIV-1 status, including viral suppression status; regular testing for STIs)
- Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment. Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection
- When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs
- Additional HIV testing to determine HIV status is needed if an HIV-1 test indicates possible HIV-1 infection or if symptoms consistent with acute HIV-1 infection develop following an exposure event. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment
- Counsel individuals without HIV-1 to strictly adhere to the recommended dosing and testing schedule for APRETUDE
Potential Risk of Resistance with APRETUDE:
- There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to test before each injection to confirm HIV-1–negative status. Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment. If individuals at continuing risk of HIV-1 acquisition discontinue APRETUDE, alternative forms of PrEP should be considered and initiated within 2 months of the final injection of APRETUDE
Long-Acting Properties and Potential Associated Risks with APRETUDE:
- Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence or missed doses could lead to HIV-1 acquisition and development of resistance
Hypersensitivity Reactions:
- Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with APRETUDE
- Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated
Hepatotoxicity:
- Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors
- Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated
Depressive Disorders:
- Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicidal ideation or attempt) have been reported with APRETUDE
- Promptly evaluate patients with depressive symptoms
Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions:
- The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE
- Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.
DRUG INTERACTIONS
- Refer to the full Prescribing Information for important drug interactions with APRETUDE
- Drugs that induce UGT1A1 may significantly decrease the plasma concentrations of cabotegravir
USE IN SPECIFIC POPULATIONS
- Lactation: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation
- Pediatrics: Not recommended in individuals weighing less than 35 kg
For more information, please see full US Prescribing Information for APRETUDE: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Apretude/pdf/APRETUDE-PI-PIL-IFU.PDF
CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspensions
Professional Indication and Important Safety Information
INDICATION
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
- Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
- Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA
- Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries
- Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction
Post-Injection Reactions:
- Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection
- Carefully follow the Instructions for Use when preparing and administering CABENUVA. The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated
Hepatotoxicity:
- Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors
- Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations
- Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected
Depressive Disorders:
- Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation, suicide attempt) have been reported with CABENUVA or the individual products
- Promptly evaluate patients with depressive symptoms
- Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
- The concomitant use of CABENUVA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions)
- Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
Long-Acting Properties and Potential Associated Risks with CABENUVA:
- Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because non-adherence could lead to loss of virologic response and development of resistance
- To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible
ADVERSE REACTIONS
- The most common adverse reactions in adults (incidence ≥2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash
- The safety of CABENUVA in adolescents is expected to be similar to adults
DRUG INTERACTIONS
- Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine)
- Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
- Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
USE IN SPECIFIC POPULATIONS
- Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA. An Antiretroviral Pregnancy Registry has been established
- Lactation: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant
For more information, please see full US Prescribing Information for CABENUVA: https://gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Cabenuva/pdf/CABENUVA-PI-PIL-IFU2-IFU3.PDF
DOVATO (dolutegravir and lamivudine) tablets
Professional Indication and Important Safety Information
INDICATION
DOVATO is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DOVATO.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HIV-1:
EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV
All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If DOVATO is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen. Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of DOVATO. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment.
CONTRADICTIONS
- Do not use DOVATO in patients with previous hypersensitivity reaction to dolutegravir or lamivudine
- Do not use DOVATO in patients receiving dofetilide
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
- Hypersensitivity reactions have been reported with dolutegravir and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury
- Discontinue DOVATO immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated
Hepatotoxicity:
- Hepatic adverse events have been reported, including cases of hepatic toxicity (elevated serum liver biochemistries, hepatitis, and acute liver failure), in patients receiving a dolutegravir-containing regimen without pre-existing hepatic disease or other identifiable risk factors
- Patients with underlying hepatitis B or C or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations with use of DOVATO. In some cases, the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn
- Monitoring for hepatotoxicity is recommended
Embryo Fetal Toxicity:
- Assess the risks and benefits of DOVATO and discuss with the patient to determine if an alternative treatment should be considered at the time of conception through the first trimester of pregnancy due to the risk of neural tube defects
- Pregnancy testing is recommended before initiation of DOVATO. Individuals of childbearing potential should be counseled on the consistent use of effective contraception
Lactic Acidosis and Severe Hepatomegaly With Steatosis:
- Fatal cases have been reported with the use of nucleoside analogs, including lamivudine.
- Discontinue DOVATO if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.
Adverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of DOVATO and other drugs may occur (see Contraindications and Drug interactions).
Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of DOVATO.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2%, all grades) with DOVATO were headache (3%), nausea (2%), diarrhea (2%), insomnia (2%), fatigue (2%), and anxiety (2%).
DRUG INTERACTIONS
- Consult full Prescribing Information for DOVATO for more information on potentially significant drug interactions
- DOVATO is a complete regimen. Coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
- Drugs that induce or inhibit CYP3A or UGT1A1 may affect the plasma concentrations of dolutegravir
- Administer DOVATO 2 hours before or 6 hours after taking polyvalent cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, DOVATO and supplements containing calcium or iron can be taken with food
USE IN SPECIFIC POPULATIONS
- Pregnancy: There are insufficient human data on the use of DOVATO during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage. An Antiretroviral Pregnancy Registry has been established. Advise individuals of childbearing potential of the potential risk of neural tube defects. Assess the risks and benefits of DOVATO and discuss with the patient to determine if an alternative treatment should be considered at the time of conception through the first trimester of pregnancy or if pregnancy is confirmed in the first trimester
- Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant
- Females and Males of Reproductive Potential: Pregnancy testing is recommended before initiation of DOVATO. Counsel individuals of childbearing potential taking DOVATO on the consistent use of effective contraception
- Renal Impairment: DOVATO is not recommended for patients with creatinine clearance <30 mL/min. Patients with a sustained creatinine clearance between 30 and 49 mL/min should be monitored for hematologic toxicities, which may require a dosage adjustment of lamivudine as an individual component
- Hepatic Impairment: DOVATO is not recommended in patients with severe hepatic impairment (Child-Pugh Score C)
For more information, please see full US Prescribing Information for DOVATO:
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/DOVATO/pdf/DOVATO-PI-PIL.PDF
About Vocabria (cabotegravir)
Vocabria injection is indicated - in combination with rilpivirine injection - for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitors (NNRTI) and integrase inhibitor (INI) class.
Vocabria tablets are indicated - in combination with rilpivirine tablets - for the short-term treatment of HIV-1 infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class for:
- oral lead-in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting Vocabria injection plus long acting rilpivirine injection.
- oral therapy for adults who will miss planned dosing with Vocabria injection plus rilpivirine injection.
Vocabria tablets are only indicated for treatment of HIV-1 in combination with rilpivirine tablets, therefore, the prescribing information for Edurant (rilpivirine) tablets should also be consulted for recommended dosing.
Please consult the full Summary of Product Characteristics for all the safety information: Vocabria 400mg/600 mg prolonged-release suspension for injection and Vocabria 30 mg film-coated tablets
About Rekambys (rilpivirine)
Rekambys is indicated - in combination with cabotegravir injection - for the treatment of HIV-1 infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class.
Rekambys should always be co-administered with a cabotegravir injection. The prescribing information for cabotegravir injection should be consulted for recommended dosing. Rekambys may be initiated with oral lead-in or without (direct to injection).
Please consult the full Summary of Product Characteristics for all the safety information: Rekambys 600mg/900 mg prolonged-release suspension for injection
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About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.
For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com.
About GSK
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References:
- E. Cordova, et al. Rapid virologic suppression with DTG/3TC facilitates early switch to CAB+RPV LA for treatment-naive people living with HIV: suppression phase outcomes from the Phase 3b VOLITION study. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.
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